This research initiative can be divided into three general areas: cross-cutting issues related to clinical research information dissemination;trial registration;and results reporting. Our research focuses on the following: 1. Cross-Cutting Issues Develop systems that facilitate comprehensive structured search and retrieval of relevant trial records by a variety of users with different levels of experience and needs. Develop systems that insert informative links from trial records to relevant content on other sites Investigate methods for harmonizing policies and procedures internationally in order to foster development of a comprehensive database with search functions that allow users to identify all registered trials, world-wide, that meet their search criteria Enhance usability, accessibility, and other features to support international users Evaluate impact of registry and results database on public, researchers, and other clinical and policy decision-makers Streamline and enhance guidance, educational, and outreach material resources and customer service infrastructure to provide enhanced support for data providers, database users, and others 2. Registration Issues Develop methods for unique trial identification, including prevention of duplicate registrations, and work with other systems (e.g., MEDLINE) to implement widespread use of ClinicalTrials.gov unique ID (NCT number) Develop methods for summarizing key aspects of study protocols, including amount of information, degree of structured data, and level of granularity to characterize the study sufficiently to satisfy a variety of users and needs Improve methods for uniquely identifying interventions, including drugs, devices, and biologics;develop and maintain a thesaurus of synonyms to optimize search functions Optimize methods for reporting pre-specified outcome measures, including identifying key sub-components and developing rules and guidelines to ensure valid entries 3. Results Reporting Issues Enhance framework for collecting summary study results data and descriptors from the full range of clinical research involving human subjects; Identify and determine methods for accommodating specific study types (e.g., diagnostic accuracy studies, adaptive study designs, dose-ranging studies) Develop study display screens that are structured, convey key information, and provide useful resource information while minimizing opportunities for bias and misunderstanding Apply the Consolidated Standards of Reporting Trials (CONSORT) statements and other study reporting guidelines to ensure that optimal data entry can be achieved Work with domain-specific experts and professional groups to develop banks of useful baseline and outcome measures Evaluate quality control methods for determining whether results records meet minimal database requirements 4. Collaborations Develop mechanisms to enhance the utility of ClinicalTrials.gov data for researchers, including search (academic site), display (tabular view), and standardized data sets Investigate potential trends and practices in the clinical research enterprise in the US and worldwide using the database Identify and suggest best practices in reporting information on clinical research
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